Global vision on prudent use

of antimicrobial agents in

food animals

• Department of Veterinary Public Health;

Research Unit in Microbial Food Safety and Antimicrobial Resistance;

Center of Antimicrobial Resistance Monitoring in Foodborne Pathogens (in cooperation with WHO);

Global Infections Network: South-East Asia and Western Pacific region

http://mountainsandmountaineers.blog.com/

Infection prevention

Research intervention

Rational use & Regulation

AMU & AMR surveillance

Clean animal husbandry

Public education

Prudent: wise and careful in action or judgment avoiding risks

Responsible: having an obligation to do something, or

having control over or care for someone,

as part of one's job or role

Judicious: having or showing reason and good judgement making decision

NOT a direction of antibiotic use

Prudent use:

Usage of antimicrobials,

which maximizes therapeutic

effect and minimizes the

development of antimicrobial resistance (WHO, 2000)

Responsible use:

The use of animal medicines

carries with it responsibilities

(Veterinarians’ and

Farmers’) (RUMA, 2005).

Organization Guideline

American Veterinary

Medical association, 2007

Judicious use of Antimicrobials in Poultry

Federation of veterinarians

of Europe,1999

Antibiotic Resistance & Prudent use of Antibiotics in

Veterinary Medicine

OIE, 2011 Antimicrobial resistance: responsible and prudent use

of antimicrobial agents in veterinary medicine

WHO, 2000 WHO Global Principles for the Containment of

Antimicrobial Resistance in Animals Intended for Food

Australian Veterinary

Association, 2005

Guidelines for Prescribing, Authorizing and

Dispensing Veterinary Medicines

AVPA, 2001 Code of practice for the use of antibiotics in the

poultry industry

JETACAR, 1999 The use of antibiotics in food-producing animals:

antibiotic-resistant bacteria in animals and humans

EPRUMA, 2008 European Platform for the Responsible Use of

Medicines in Animals

Organization Guideline

USDA/FDA, 2012 Guidance for Industry # 209 The Judicious Use of Medically

Important Antimicrobial Drugs in Food-Producing Animals

World Veterinary

Association, 2011

Draft position paper on responsible use of antimicrobials:

The Global Basic Principles

EU, 2015 Guidelines for the Prudent Use of Antimicrobials in Veterinary

Medicine 2015/C 299

Alliance for the Prudent

Use of Antibiotics

Antibiotics Use in Food Animals

Canadian Food Inspection

Agency

Prudent Use of Veterinary Drugs in Livestock Feeds

Canadian Veterinary

Medicine Association

Guidelines on the Prudent Use of Antimicrobial Drugs in Animals

Guardabassi and Kruse,

2008

Principles of Prudent and Rational Antimicrobial Use in Animals.

In Guide to Antimicrobial Use in Animals

WHO, 2017 Guidelines on use of medically important antimicrobials in food -

producing animals

Not so restrictively as to replace professional judgement of practitioners or to compromise animal health or welfare.

Species-specific clinical practice guidelines on the responsible use of veterinary antimicrobial drugs

Make recommendations on different AMU but vet will determine the final choice.

Developed with multidisciplinary

Support by scientific data & knowledge; disease & AMR situation

Subject to peer review

Compatible with existing regulation

Human concern

Revised regularly

World Veterinary Association

1. Antibiotics are health management tools that are licensed to

be used to enhance good husbandry practices for the purpose

of disease prevention, disease treatment and production enhancement

2. Codes of good practices, Quality assurance programmes,

Herd Health Surveillance Program, and education

programmes should promote the responsible and prudent use of antibiotics.

3. Antibiotics shall be used under the supervision of a veterinarian.

4. Therapeutic antibiotics should be used when it is known or

suspected that an infectious agent is present which will be

susceptible to therapy. It is the responsibility of the

veterinarian to choose the antibiotic product, based on his/her

informed professional judgement balancing the risks and benefits for humans and animals.

5. When antibiotics need to be used for therapy, bacteriological

diagnosis with sensitivity testing should, whenever possible,

be part of the informed professional clinical judgement.

6. Label instructions should be carefully followed and

due attention paid to species and disease indications

and contra-indications, dosage regimen, withdrawal

periods, and storage instructions. Off-label use of

antibiotics should be exceptional and always be under the professional responsibility of a veterinarian.

7. Antibiotics used for therapy should be used for as

long as needed, over as short a dosage period as possible, and at the appropriate dosage regimen.

8. Records should be kept of all antibiotic administrations.

9. Co-ordinated susceptibility surveillance should be

conducted and the results be provided to the,

prescriber, supervising veterinarians and other relevant parties

10. Efficacious, scientifically proven alternatives to

antibiotics are needed as an important part of good husbandry practices.

Medically important antimicrobials used in

human medicine

Summary of classification and prioritization of antimicrobials

Summary of classification and prioritization of antimicrobials

(cont.)

Veterinarians and livestock farmers.

1. Prevention of infection

･The standards of Rearing Hygiene Management

･The guidelines on good hygienic practice

2. Definite diagnosis

Identify the cause of infection and determine tx measures

based on veterinarian’s definite diagnosis

3. Effective use of antimicrobials

・Choose effective antimicrobial drugs with sensitivity test

・Fluoroquinolones, 3rd generation cephalosporins, etc. should be used

only if the first choice drug is not effective

4. Information sharing

Share information about AMR bacteria among the relevant parties

Main Points:

• avoiding the prophylactic use of antimicrobials in new-born

piglets (and after weaning), as a part of a herd health strategy;

• implementing an ‘all-in all-out’ system of production, thoroughly

cleaning and disinfecting production units when animals move

into, within and out of the herd;

• considering a vaccination strategy where available;

• establishing appropriate feeding strategies based on the pigs'

age, especially at weaning;

• avoiding mixing within the herd, or quarantining stock for an

appropriate period prior to mixing;

• Antimicrobials should not be used routinely on the arrival of day-

old chicks at the farm.

• The use of antimicrobials for non-infectious diseases with limited

secondary infections should be avoided.

• The use of 3rd and 4th generation of cephalosporins in poultry

(including eggs) should be prohibited.

• Fluoroquinolones should be reserved for the treatment of clinical

conditions that have responded poorly, or are expected to respond

poorly, to other classes of antimicrobials and, whenever possible,

should only be used where susceptibility testing has first been

carried out.

• Antimicrobials shall not be used as a specific method to control

Salmonella.

• Ensuring alignment between human and veterinary sectors to minimise risks arising from use of antibiotics

• Adopts a ‘One Health’ approach but recognises the specific

nature of the human and veterinary sectors

• Different priorities drive the activities

For human, medicines promote the availability of

antimicrobials to treat multidrug resistant organisms

For veterinary, medicine ensure the continued availability

of veterinary antimicrobials whilst limiting the risk to man from the use of antimicrobials in animals

Animal

ONE

HEALTH

http://www.fda.gov

CategoryRisk to Public

HealthAntimicrobials Included Advice on use

1Low/limited risk to

public health

Narrow spectrum Penicillins,

Macrolides, Tetracyclines

General principles of

responsible use to be

applied

2Higher risk to

public health

Fluoroquinolones, systemic 3rd

/4th generation Cephalosporins,

(Aminoglycosides, broad-

spectrum Penicillins), Colistin

Restricted to use where

there are no alternatives or

response to alternatives

expected to be poor

Fluoroquinolones, 3rd and 4th generation cephalosporins

and colistin are recognised as the most important of the CIAs, as designated by EMA.

http://www.fda.gov

• Does not have the force of law.

• Provides the agency’s position on regulatory matters

• Voluntary is relative.

• #152 provides guidance on evaluating the potential

effects of antimicrobial new animal drugs on non-target

bacteria as part of the new animal drug application

process.

• Two key principles:

1. Limit use of medically important antimicrobial drugs to

those uses considered necessary for assuring animal

health (i.e., therapeutic purposes)

2. Increase veterinary involvement/consultation

• Use for growth promotion and nutritional efficiency of

antibiotics in classes used in human medicine are injudicious

or was bot called unsafe.

• Uses of the others in the same classes of antibiotics are under

veterinary oversight.

• Discontinuing claims or migrating production claims to disease

prevention is voluntary work.

• Initiating step

• Goal to preserve availability

of effective ABO for both human and animals.

• Provides more detailed guidance on implementation

of key principles in Guidance 209

• Growth Promotion and Nutritional Efficiency labels

was removed by Dec. 2016.

• Remaining therapeutic uses under VFD or

prescription for affected products (Medically

Important).

• Most growth promotion uses will end within 3 years.

• Most feed grade antibiotics will no longer be

available over-the-counter but will require

• a veterinary “order”.

• Administered in feed/water is Rx.

• Stakeholder concerns that removing production

uses might negatively impact animal health.

• Potential new therapeutic uses

• Therapeutic = treatment, control, prevention

• All OTC to Rx or VFD.

• Assume the responsibility for making clinical

judgements and the need for medical tx.

• Have sufficient knowledge of the flock &

recently seen the flock.

• Be readily for consultation and follow-up

evaluation & emergency.

Veterinarian-Client-Patient relationship (VCPR).

(AVMA, 2005)

https://www.avma.org

Classification of antimicrobials based on

importance and use in both human and poultry

Class I: Important in human medicine; to be held in reserve for treatment

in poultry

Class II: Human medicine use where alternatives exist; exposure in poultry

is moderate; erythromycin, penicillin, gentamicin,

sulfonamides, cefiofur, tetracycline class

Class III: No or minimal use in human medicine or low exposure in poultry;

bacitracin, streptomycin, tylosin, lincomycin, spectinomycin,

neomycin

• Use narrow-spectrum antimicrobials whenever appropriate.

• Use microbial culture and antimicrobial susceptibility results to

aid in the selection of antimicrobials when clinically relevant.

• Regimens for antimicrobial treatment, control, or prevention of

disease should be based upon current scientific and clinical

principles, such as microbiological and pharmacological tenets.

• To minimize selective pressure, therapeutic exposure to

antimicrobials should be minimized by treating only for as long

as needed for the desired clinical response.

• Limit therapeutic antimicrobial treatment to ill or at-risk animals,

treating the fewest animals indicated.

Antimicrobials should be used in animals only after careful review.

vetcufsar@gmail.com

Research Unit in Microbial Food Safety &

Antimicrobial Resistance

Center for Antimicrobial Resistance Monitoring

in Foodborne Pathogens (in cooperation with WHO)

GFN: SE Asia & Western Pacific

Department of Veterinary Public Health

Faculty of Veterinary Science,

Chulalongkorn University

CLSI: Advisory committee for CUARM